Physician Office Laboratories: Stark, AKS, Fee-Splitting Prohibitions, Medical Necessity, and Other Legal Issues

Recording of a 90-minute CLE video webinar with Q&A

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Conducted on Wednesday, April 13, 2022

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Course Materials

This CLE webinar will guide healthcare counsel on legal issues with physician office laboratories (POLs). The panel will address Stark, AKS, fee-splitting prohibitions, medical necessity, and other legal issues. The panel will offer best practices for mitigating risks and ensuring compliance with the regulatory requirements.

Description

Many physician practices or physician groups maintain POLs, which perform common lab tests. Like most aspects of the healthcare industry, POLs are highly regulated and face numerous federal and state requirements including licensing and reimbursement, as well as fraud and abuse laws.

The Stark law prohibits referrals by physicians to an entity in which they have a financial interest absent an exception. There are several Stark exceptions that may apply, including the In-Office Ancillary Services Exception, which allows a physician or group practice to refer and provide clinical laboratory services within the practice. In addition to Stark, POL arrangements must be analyzed under the Anti-Kickback Statute.

In addition to being concerned about Stark and AKS, physicians and physician groups must be careful to not run afoul of other regulatory issues, including fee-splitting prohibitions and medical necessity requirements.

Listen as our authoritative panel of healthcare attorneys examines POLs and the legal issues they face. The panel will address Stark, AKS, fee-splitting prohibitions, medical necessity, and other legal issues. The panel will offer best practices for mitigating risks and ensuring compliance with the regulatory requirements.

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Outline

  1. POLs
  2. Legal/regulatory challenges
    1. Stark and exceptions
    2. AKS and safe harbors
    3. Fee-splitting
    4. Medical necessity
    5. Others
  3. Best practices
    1. Risk mitigation
    2. Regulatory compliance

Benefits

The panel will review these and other key issues:

  • What problematic POL models potentially trigger Stark and AKS violations?
  • What Stark exceptions can physician practices apply to provide laboratory services?
  • What steps can healthcare counsel and their clients take to mitigate the risks associated with POLs?

Faculty

Dresevic, Adrienne
Adrienne Dresevic

Founding Partner
The Health Law Partners

Ms. Dresevic practices in all areas of healthcare law and devotes a substantial portion of her practice to providing...  |  Read More

Walters, Adam M.
Adam M. Walters

Principal
Walters Law

Mr. Walters represents healthcare providers in a wide variety of matters including business transactions, fraud...  |  Read More

White, Courtney
Courtney M. White

Attorney
Dinsmore & Shohl

Ms. White focuses on regulatory, operational, corporate, and transactional matters. She provides practical and...  |  Read More

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